UnitedHealthcare Rubraca Prior Auth Policy Update

Coverage Criteria — Indication-specific Requirements

Initial Authorization — Ovarian / Fallopian Tube / Primary Peritoneal

Covered when ALL of the following are met for patients <19 or initial authorization for ovarian/fallopian tube/primary peritoneal:

Pediatric auto-approval: Patient is less than 19 years of age

Prescription auto-processes without a coverage review for members under 19

Epithelial ovarian/fallopian tube/primary peritoneal – initial: Diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer AND cancer has a deleterious BRCA mutation AND used as maintenance therapy in individuals in complete or partial response to platinum-based chemotherapy

Reauthorization — Ovarian / Fallopian Tube / Primary Peritoneal

Reauthorization — Ovarian/fallopian tube/primary peritoneal

Reauthorization: Patient does not show evidence of progressive disease while on Rubraca therapy

Authorization will be issued for 12 months

Initial Authorization — Metastatic Castration-Resistant Prostate Cancer

Initial Authorization — Prostate cancer

Diagnosis: Metastatic, castration-resistant prostate cancer

Mutation: Cancer has a deleterious BRCA mutation

Prior therapy requirement: History of failure, contraindication, or intolerance to androgen receptor-directed therapy (e.g., abiraterone, enzalutamide, apalutamide)

Androgen suppression: Used in combination with a GnRH analog OR patient has had bilateral orchiectomy

Examples of GnRH analogs: leuprolide, goserelin, triptorelin, histrelin, degarelix

Reauthorization — Prostate Cancer

Reauthorization — Prostate cancer

Reauthorization: Patient does not show evidence of progressive disease while on Rubraca therapy

Authorization will be issued for 12 months

Initial Authorization — BRCA altered uLMS

Initial Authorization — Uterine leiomyosarcoma (uLMS)

Diagnosis: BRCA altered uterine leiomyosarcoma (uLMS)

Prior progression: Disease has progressed following prior treatment with gemcitabine plus docetaxel OR doxorubicin

Authorization will be issued for 12 months

Reauthorization — uLMS

Reauthorization: Patient does not show evidence of progressive disease while on Rubraca therapy

Authorization will be issued for 12 months

Initial Authorization — Pancreatic Cancer

Initial Authorization — Pancreatic adenocarcinoma

Diagnosis: Pancreatic adenocarcinoma

Mutation requirement: Presence of deleterious or suspected deleterious germline or somatic BRCA1/2 mutation OR deleterious or suspected deleterious germline or somatic PALB2 mutation

Platinum response: Disease has not progressed while receiving at least 16 weeks of a first-line platinum-based chemotherapy regimen>= 16 weeks

Reauthorization — Pancreatic Cancer

Reauthorization — Pancreatic cancer

Reauthorization: Patient does not show evidence of progressive disease while on Rubraca therapy

Authorization will be issued for 12 months

NCCN Recommended Regimens

NCCN category: Drug recognized by NCCN Drugs and Biologics Compendium with Category of Evidence and Consensus of 1, 2A, or 2B

May support coverage per program rules

General authorization and approval rules

Covered when the following contextual rules are met or considered

Authorization duration: Authorization will be issued for 12 months.12 months

See state mandates and member-specific benefit plan coverage.

Approval considerations: UnitedHealthcare may approve initial and re-authorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic.

Use of automated processes varies by program/therapeutic class.

Disease status requirement: Disease is metastatic.metastatic

Referenced in criteria.

Some states have laws that require coverage of off‑label medication uses or adherence to specified clinical compendia. Where a state mandate applies to a member’s benefit, that mandate supersedes the language and requirements in this policy.

Historic program notes document prior revisions and additions to Rubraca review criteria over time, including the program’s creation following FDA approval in 2016 and subsequent annual updates. These historical entries record when indications and supporting references were added or narrowed (for example, inclusion of prostate, uterine, and pancreatic indications per NCCN review and the later narrowing of maintenance ovarian criteria to patients with a deleterious BRCA mutation). The references list reflects prior operational and clinical changes but does not enumerate every exclusion in this excerpt.

Requests that do not meet the specified coverage criteria for the requested indication may be denied. UnitedHealthcare may also deny or decline to require full clinical review when previous claim/medication history, diagnosis codes (ICD‑10), or claim logic do not support approval. Note that prescriptions for members under 19 years of age are automatically processed without coverage review unless a state mandate or member benefit specifies otherwise.

Provider Actions, Documentation, and Authorization Procedures

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization is required for Rubraca (rucaparib) and will be approved only when the indication-specific criteria in the coverage section are met. Failure to meet the specified coverage criteria may result in denial of the request.

Authorization period: 12 months (see applicability notes).
State mandates and member-specific benefits may supersede these criteria.

Denial Risk

Denial Risk and Pediatric Auto-Processing

Denial Risk if Criteria Not Met: Requests may be denied if documentation does not support the diagnosis, prior therapies, or genetic alteration required by the specific indication. For members under age 19, prescriptions will automatically process without coverage review.

Denials may occur when prior therapy requirements (where specified) or genetic testing results are not documented.

Initial Therapy — Indication-Specific Initial Approval Logic

Initial Therapy

See indication-specific nodes: Refer to coverage criteria per indication (ovarian/fallopian/primary peritoneal; prostate; uLMS; pancreatic)

Initial therapy

Automated or history-based approval: UnitedHealthcare may approve initial authorization based on previous claim/medication history, diagnosis codes and/or claim logic.

Automated approval use varies by program.

Reauthorization / Continuation Criteria

Reauthorization / Continuation Therapy

Reauthorization requirement across indications

Continuation requirement: Patient does not show evidence of progressive disease while on Rubraca therapy

Authorization issued for 12 months

Re-authorization

Re-authorization rules

Re-authorization duration: Authorization will be issued for 12 months.12 months

Re-authorization may rely on prior claims and diagnosis codes.

Step Therapy and Prior Systemic Therapy Requirements

Required prior systemic regimen	Notes
Gemcitabine plus docetaxel	Disease must have progressed following prior treatment with gemcitabine plus docetaxel
Doxorubicin	Disease must have progressed following prior treatment with doxorubicin

Historical step requirement	Current status / change
Taxane‑based chemotherapy requirement for prostate cancer (historical)	Removed from current criteria per updated guidance (see Change Control); requirement no longer applies

Background — Drug, Indications, and References

Rucaparib (Rubraca) is a poly(ADP‑ribose) polymerase (PARP) inhibitor. It is indicated for maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer associated with a deleterious BRCA mutation following response to platinum‑based chemotherapy, and for treatment of deleterious BRCA mutation–associated metastatic castration‑resistant prostate cancer after androgen receptor–directed therapy (and historically with taxane chemotherapy noted). The program history also documents additions of NCCN‑recommended uses (including certain uterine leiomyosarcoma and pancreatic cancer scenarios) and later updates narrowing or removing prior step requirements in alignment with prescribing information and NCCN guidance.

Definitions and Key Terms

BRCA mutation (germline and/or somatic)

DefinitionDeleterious BRCA mutation (germline and/or somatic) — a pathogenic alteration in BRCA1 or BRCA2 identified in either the germline or tumor (somatic) that is associated with sensitivity to PARP inhibitor therapy.

Context — ovarian indicationRubraca is indicated for maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients with a deleterious BRCA mutation (germline and/or somatic) who are in complete or partial response to platinum-based chemotherapy.

Context — prostate indicationRubraca is indicated for treatment of metastatic castration‑resistant prostate cancer associated with a deleterious BRCA mutation (germline and/or somatic).

Testing implicationBRCA status may be established by germline or somatic testing per the indication (either source of mutation qualifies).

Clinical relevancePresence of a deleterious BRCA1/2 mutation is required by the policy for covered indications specified (e.g., ovarian maintenance, mCRPC, select uLMS and pancreatic indications).

Quantity Limits and Drug Supply Constraints

rucaparib (Rubraca) — quantity/supply limits

Drugrucaparib (Rubraca)

Quantity limits noteSupply limits may be in place for rucaparib; authorization and dispensing may be subject to program-specific quantity/supply restrictions.

Authorization relianceUnitedHealthcare may use previous claim/medication history and claim logic when applying supply limits and approving requests.

Administrative noteUse of automated approval and re-approval processes varies by program and/or therapeutic class; quantity limits are part of utilization management controls.

OpenPayer

Rubraca (rucaparib) prior authorization

Coverage Criteria — Indication-specific Requirements

Provider Actions, Documentation, and Authorization Procedures

Initial Therapy — Indication-Specific Initial Approval Logic

Reauthorization / Continuation Criteria

Step Therapy and Prior Systemic Therapy Requirements

Background — Drug, Indications, and References

Definitions and Key Terms

Quantity Limits and Drug Supply Constraints